Surgically implantable mesh patches for the repair of inguinal and other abdominal wall hernias, which are intended for permanent placement within a patient's body space, have been provided and used previously as set forth, for examples, in the following U.S. patents:
In 1954, Benjamin F. Pease, Jr., in his U.S. Pat. No. 2,671,444 illustrated and described his nonmetallic mesh surgical insert for hernia repair, comprising a sheet of relatively fine uniform open mesh work of a durable, permanently pliable, non-toxic radiation permeable resinous material, which was compatible with body tissues and fluids, and inert chemically with respect thereto. All the joints of the mesh work were preferably unitary, in consequence of which the surgeon could trim the she, of open mesh work to any desired size and shape, without any danger of it unraveling. The cut edge provided an adequate strong portion for suturing the mesh work to the patient's body tissues at any convenient location. The mesh work itself promoted the ready growth therethrough of the patient's own repair tissue. The mesh work insert was adapted to remain permanently in the patient's body, facilitating the body's own efforts to repair the hernia, and minimizing the chance of reoccurrence, without the danger of future difficulties because of irritation, corrosion, or the like.
In 1962, Francis C. Usher in his U.S. Pat. No. 3,054,406, illustrated and described his improved surgical mesh which was intended to be held in place by sutures. This surgical mesh was made of a polyethylene thread, free of water leachable irritant impurities and having a tensile strength of at least 50,000 p.s.i., and a weight from 100 to 500 denier. The threads of the improved surgical mesh were spaced at intervals in the range of 5 to 50 mils. These threads were unattached to each other at their points of crossing. This improved surgical mesh was physiologically inert even in the presence of any possible infection.
In 1982, Francis C. Usher in his U.S. Pat. No. 4,347,847, continued describing and illustrating his improvements in providing surgical mesh and the method of the use thereof in hernia repair. In his method of repairing hernias and other defects of the abdominal and chest wall, he placed a tubular surgical mesh over the defect in its flattened form to provide continuous border edges. The tubular surgical mesh was of a size sufficient to bridge the defect, and to position the continuous border edges thereof on tissue adjacent the opposite sides of the defect, free of selvage edges. He then sutured through the mesh adjacent the continuous border edges to the tissue. The surgical mesh was comprised of monofilament threads which were free of water leachable irritant impurities and were physiologically inert, even in the presence of infection. The monofilament threads had a tensile strength sufficient, when doubled, to withstand wound tension. The threads of the mesh had a diameter in the range of 5 to 15 mils. The mesh was formed having 10 to 20 stitches per inch, and during the formation a continuous tubular shape was created. The threads were unattached to each other at their points of crossing. The threads were made of a polypropylene monofilament.
In 1992, Mark A. Eberbach in his U.S. Pat. No. 5,116,357, illustrated and described his hernia plug and introducer apparatus. Mr. F. Eberbach provided, via a laparoscopic system, a plug and patch assembly comprising a cylindrical plug of flexible material, positionable in an opening in the abdominal wall to be repaired, with the plug being in contact with the opening. The plug had a distal end and a proximal end. Then there was a patch of an inextensible and flexible mesh material to be positioned over weakened portions of the abdominal wall adjacent to the opening. A central extended portion of the patch was coupled to the proximal end of the cylindrical plug, with the periphery of the patch being remote from the plug, and constituting a flange. Then a resilient small cross-sectional diameter adjustable loop of ribbon material, constructed of surgically antiseptic material, was used to keep the patch extended in the intended location thereof, both over and beyond the weakened portions of the abdominal wall. A surgeon using conventional laparoscopic techniques finally positioned the patch, after the initial placement of this loop of ribbon material.
Also in 1992, Mark a Eberbach in his U.S. Pat. No. 5,122,155, illustrated and described another of his hernia repair apparatus and method of use. His laparoscopic repair of abdominal hernias by a surgeon, through patching of a weakened portion of the abdominal part to be repaired, comprised the steps of:
"providing a patch formed of flexible, inextensible material and positionable in a plane adjacent to the weakened portions of the abdominal part to be repaired, the patch having an elongated passageway located in the plane of the patch adjacent to the majority of the periphery of the patch, the passageway having an opening at one end thereof; PA1 providing an elongated interior ribbon having a distal end positioned through the opening of the passageway and slid able within the passageway, the ribbon being sufficiently rigid whereby it may be remotely pushed into the passageway; PA1 providing an elongated intermediate cylindrical plunger having an interior slid ably receiving the ribbon, the plunger having a distal end coupled to the patch and a proximal end to be manipulated by the surgeon; PA1 providing an elongated exterior cylindrical sheath having an interior slid ably receiving the plunger, the ribbon and the patch, the sheath having a distal end adjacent to the patch and a proximal end to be manipulated by the surgeon, the sheath being of a length to extend from exterior of a patient through a laparoscopic port into a surgical cavity which includes the part to be repaired; PA1 positioning the patch and the distal ends of the ribbon, plunger and sheath into a patient adjacent to the area to be repaired; PA1 advancing the patch and plunger from the sheath; PA1 advancing the ribbon into the passageway of the patch to expand the patch; PA1 coupling the patch to the area to be repaired; PA1 withdrawing the ribbon from the patch; PA1 separating the patch from the plunger; and PA1 withdrawing the ribbon, plunger and sheath from the patient."
Also in 1992, Alfredo Fernandez illustrated and described his prosthetic mesh patch for laparoscopic hernia repair. His mesh patch, which was inserted through the opening in the patient to be repaired, was a rolled up sheet of surgical plastic mesh maintained in a rolled up form by attaching at least two bands around it. Then he made multiple longitudinal cuts in the first end of this rolled up mesh to form multiple flared out flaps. The flaps were then stitched to a planar sheet of plastic surgical mesh. The overall patch was then inserted into the patient's opening, by using a second end of the rolled up sheet of surgical plastic. In this way, the rolled portion of the patch entered the patient's opening, and the flaps and the planar sheet of plastic surgical mesh were displayed out over an entrance to the patient's opening. Thereafter the planar sheet of plastic surgical mesh was stapled to adjacent tissue of the patient to retain the patch in position; and
In 1993, Arnold S. Seid in his U.S. Pat. No. 5,254,133 illustrated and described his surgical implantation device and related method of use to seal an enlarged, generally circular opening in the wall of one of the patient's body cavities. He provided a surgical implantation device having a generally planar first portion and second portion which were interconnected by a connecting segment. He then inserted and located one end of a surgical tube through the patient's wall opening and adjacent a first side of the wall. Then be forced the first portion of the surgical implantation device out of the surgical tube adjacent the first side of the wall, and allowed this first portion to automatically assume a planar shape. Thereafter he forced the connecting segment of the surgical implantation device out of the surgical tube to be within the wall opening. Subsequently, he forced the second planar portion of the surgical implantation device out of the surgical tube adjacent a second side of the wall, and allowed this second portion to automatically assume a planar shape. Then he passed a suture through the first portion, the connecting segment, and the second portion of the surgical implantation device, and tied off the suture to attach these three portions together. Finally, he withdrew the surgical tube from the patient. Resilient members were respectively attached to either the first of the second portions, which were initially flexible enough to be folded into the surgical tube. Thereafter, when they were cleared from the surgical tube, they unfolded into a planar orientation with their respective first or second portions.
These inventors in illustrating and describing their patches and their ways of using their patches, led the way of creating tension free surgical repairs of hernias using synthetic mesh materials to bridge and to patch hernia defects. These repairs resulted in both a decrease in the recurrence rate as well as a decrease in the amount of a patient's post operative discomfort. Patients undergoing these more advanced procedures were able and are able to resume their normal activities sooner. As realized, some of these earlier inventions are somewhat complicated or are complicated. Several use some type of a plug or a locating member to fit within the hernia defect itself. Also many of these earlier inventions were designed specifically for use in laparoscopic repair of hernias. Moreover, many of the prior inventions regarded their suturing to the patient's body tissue. Although these medical advances are acknowledged for their usefulness and success, there remained a need or needs for more improvements in the surgical repair of hernias.